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EASAC 

Realising European potential in synthetic biology | December 2010 |    15

but key developments are discussed at the following 

websites:

•   www.etp-nanomedicine.eu, the European 

Technology Platform on nanomedicine. A Vision 

Paper was published in 2005 and the Strategic 

Research Agenda in 2006. A recent meeting in 

the European Parliament reviewed nanomedicine 

developments analysed by the NanoMed 

Round table, funded by the Seventh Framework 

Programme

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.

•   www.nano.gov, the US national nanotechnology 

initiative. The US National Institutes of Health 

(NIH) focus on nanomedicine is available at http://

nihroadmap.nih.gov/nanomedicine.

The research portrayed in these examples falls within 

the remit of what is usually termed nanotechnology. It is 

probably premature as well as unnecessary to attempt 

any demarcation that would assign individual approaches 

unambiguously as synthetic biology rather than 

nanotechnology although, in time, the precise defi nition 

of synthetic biology (chapter 2) may come to exclude 

research within the broader fi eld of bionanosciences. 

The currently blurred boundary does not apply just to 

molecular motors. For example, some recent suggestions 

for possible customised applications in biology-inspired 

nanotechnology to fi ght infectious diseases (Morris 2009) 

might also be seen as qualifying as synthetic biology.

A detailed discussion of the current scientifi c status of 

nanotechnology is beyond the scope of this EASAC report 

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June 2010, ‘Nanomedicine in Europe: present and for the future’.

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EASAC 

Realising European potential in synthetic biology | December 2010 |    17

6.1  Identifying what is new

Does synthetic biology bring qualitatively new governance 

challenges or merely an extension of known issues? 

Many emerging technologies elicit social concerns but 

experience teaches that the social and ethical issues arising 

from the application of new technologies are rarely new or 

unique to that technology. However, whenever signifi cant 

social and ethical issues arise, they must be addressed, 

irrespective of whether they are genuinely new.

In the joint Royal Society (2008b) report with the 

Science Council of Japan it was remarked that new and 

emerging technologies present challenges for national 

and international governance, particularly when their 

development and impact is faster than the construction 

of international safeguards. This may require new models 

of international co-operation in governance. Appraisal 

of the governance framework issues for synthetic 

biology can draw on those previously described for other 

emerging technologies, for example, for nanotechnology 

(Royal Society and Royal Academy of Engineering 2004). 

Acceptance and use of a new technology will depend 

upon a range of social factors associated with whoever 

controls the technology and whoever benefi ts from 

its exploitation—individual consumers and political 

decision-makers, within the broader macro-economic 

environment. The impact of any new technology can 

be located on a continuum between the extremes 

of incremental progress and radical disjunction. One 

noteworthy point might be emphasised in the context 

of the Royal Society and Royal Academy of Engineering’s 

report on nanotechnology. At that time (2004), their 

report noted especial public concern about the notion of 

self-replicating systems but judged that outcome to be 

some considerable time in the future. In consequence of 

the scientifi c advances made in synthetic biology since 

2004, it may be that this future point has come much 

nearer. The options for an ethical framework for synthetic 

biology are discussed in a Focus issue of the Journal of the 

Royal Society Interface

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. We emphasise a key issue here 

in terms of the responsibilities of academies: the scientifi c 

community must encourage open debate and warn of 

the consequences if excessive regulation inadvertently 

constrains scientifi c advance. Furthermore, it is vital for 

the academies, research funders and other scientifi c 

bodies to provide accessible and accurate information 

about synthetic biology developments so as, pro-actively, 

to inform the broader debate rather than simply reacting 

to the latest alarmist assertions in the media. EASAC 

advises also that the academies must do more to support 

continuing discussion of the ethical issues within the 

broader societal and philosophical contexts and EASAC 

recommends that the All European Academies (ALLEA) 

should consider initiating such discussion within their 

Standing Committee on Science and Ethics

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.

There is a lot that can be done by the scientifi c community 

to develop a framework that ensures safety of research 

and product use. There are two main objectives: 

(1) biosafety, which encompasses the protection of 

legitimate users and (2) biosecurity, protecting against 

the intentional misuse of biosciences, whether at the 

State level, by a terrorist organisation or by the misguided 

individual (increasingly possible in consequence of the 

progressive ‘deskilling’ of biotechnology

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). As the 

Netherlands Academy report notes, there are some 

important practical questions to answer. Are effective 

and adequate protection measures in place if these 

microorganisms unintentionally fi nd their way into 

the wider environment? How controllable are these 

microorganisms if their application lies outside the 

laboratory or factory? Is the world adequately protected 

against biohackers and bioterrorism, now that standard 

biological components are so easy to obtain?

Both biosafety and biosecurity were discussed extensively 

at the Berlin meeting (Appendix 1). The following 

material draws on that discussion and the publication 

of the German Statement, which concludes that the 

aims of synthetic biology do not yet mandate additional 

requirements to ensure biological safety in laboratories or 

on deliberate release, and do not incur risks with regard 

to possible misuse other than those arising from genetic 

engineering. And, as noted in previous sections, the 

methodologies involved in synthetic biology can be used 

as means to engineer additional safety, for example by 

creating dependence on exogenous nutrients or inducers, 

or on endogenous subsystems.

6.2 Biosafety

Risks might arise from the uncontrolled, accidental, 

release of self-replicating systems outside of the research 

environment but also from the deliberate release that 

may be required for the novel application, for example 

in environmental remediation. Related issues were 

6  Safety, social and governance issues

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‘Synthetic biology: history, challenges and prospects’, organised by Haselhoff, J, Ajioka, J and Kitney, R, 2009. Available at 

http://rsif.royalsocietypublishing.org/site/misc/syntheticbiology_focus.xhtml.

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www.allea.org/Pages/ALL/12/72s.bGFuZz1FTkc.html.

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Opinions vary on the size of the threat posed by “biohacking”. Alper (2009) concluded that there is relatively little evidence 

but signifi cant hyperbole about do-it-yourself biotechnology whereas Bennett and co-workers (2009) take the threat more 

seriously. Currently, the situation is uncertain but most of the discussion emanates from the USA.

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